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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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SFG Sperm CD - 10850068289506

No Description
SPECTRUM FERTILITY GROUP INC.
S-D-SS1
In Commercial Distribution

  • 00850068289509 ()
  • 10850068289506 ()


  • Assisted reproduction procedure dish

PAP-8E Software CD - G0561071530

No Description
Bio/Data Corporation
107153
In Commercial Distribution

  • G0561071530 ()
107053

  • Platelet aggregation analyser IVD

LTA Check CD - G0561071490

No Description
Bio/Data Corporation
107149
In Commercial Distribution

  • G0561071490 ()
107149

  • von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, reagent

POWERCHO-2 CD, 100L - 00840075402763

No Description
Lonza Walkersville, Inc.
08-911D
In Commercial Distribution

  • 00840075402763 ()
08-911D

  • Ex vivo cell culture medium

CMSViewer CD(FDA) - 06944904086422

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-034054-00
In Commercial Distribution

  • 06944904086422 ()


  • Noninvasive device battery charger

Noxturnal PSG CD - 15694311111368

No Description
Nox Medical ehf.
NOX-NOXTPSG_CD
In Commercial Distribution

  • 15694311111368 ()
539012

  • Sleep disorder interpretive software, professional-only

Welch Allyn, Inc. - 00732094259711

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; UK power cord; No printer, no transport cart; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259711 ()
XSCRIBE-6CC-CXBXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259513

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; No power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259513 ()
XSCRIBE-6CC-XXAXX

  • Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. - 00732094259483

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; No power cord; No printer, no transport cart; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259483 ()
XSCRIBE-6CC-XXBXX

  • Electrocardiographic lead set, reusable

Welch Allyn, Inc. - 00732094259056

XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; No Acquisition Module; Software kit; No power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259056 ()
XSCRIBE-6XC-XXAXX

  • Cardiopulmonary stress exercise monitoring system computer
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